Learned all about the Emilia clinical trial on this vacation?

Published 12:00 am, Sunday, June 26, 2011

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Vacationing in southeastern Connecticut last week, I took a side trip to Backus Hospital's resident oncology and hematology group, Eastern Connecticut Hematology Oncology.

I was invited there to learn about a clinical trial in which the practice is participating, the Emilia Trial. It's a clinical trial for an investigational drug for those who have already been diagnosed with HER2 breast cancer, and are having a recurrence.

The drug that is being tested is Trastuzumab-DM1. In the past, it has been known to be quite toxic. But this time, researchers are trying to figure out if the drug will work better combined with two others that are equally hard to spell or say: capecitabine and lapatinib.

Already, the latter two have been approved by the Food and Drug Administration for the treatment of patients whose advanced or reoccurring tumors overexpress HER2.

I may have explained to you in the past that there are several different kinds of breast cancers.

About 20 percent of breast cancer patients have an overexpression of HER2, a receptor on cancer cells. It is believed that the overexpression plays a direct role in aggressive growth and poor clinical outcomes.

Just to put things in perspective, it was only a mere eight years ago when a clinical trial determined that herceptin was the drug to give women with the HER2 overexpression.

"Herceptin was the biggest breakout in cancer research," and has since become the new standard, according to Rose B. Gerber, director of patient advocacy for the Community Oncology Alliance of Washington, D.C.

Gerber was one of the people who participated in the trial when she was 39. Once diagnosed with HER2 positive breast cancer, she wanted to stay alive for her children, who were 6 and 8 at the time, as well as for her husband.

As you may know, the relationship between oncologist, oncology nurse and patient is often precious and close. Gerber developed such a good relationship with Mortoro and Dr. Jaga, as she is known, that it continues today. So, Gerber is helping to promote the clinical trial. She wants others to know that they should take advantage of clinical trials when available.

Lynn said researchers are excited about the Emilia Trial because the T-DM1 goes directly to the cancer cells. "Scientists and researchers are looking at this new combination of drugs to see if it's more effective than the current standard," she said.

ECHO is a "tiny wedge" in the pie; so far, only one patient has met the trial's criteria, and they are recruiting more. Call Mortoro at 860-886-8362.

Numerous places across the country are participating in and recruiting for the trial. Besides ECHO in Norwich, other places recruiting are Greenwich Hospital, Hematology Oncology PC of Stamford and Oncology Associates of Bridgeport-Trumbull.

As with all trials, unless the numbers are up, you cannot deem the promise of a new drug.

At ECHO, Dr. Anca Bulgaru says that the practice "takes pride in offering" novel treatments to patients to improve their life expectancy and quality of life, as well as controlling symptoms of cancer treatment. The practice is active in offering clinical trials, she said.

"By offering trials, we save patients a trip to academic centers. It's the promise of better treatment in the comfort of home, and close management and treatment by doctors who know them best," she said.

"I hope this trial will help us find new treatment for patients with metastatic breast cancer who are HER2 positive," the doctor said.

Gerber said that 60 percent of clinical trials take place in community settings. "That you get subpar treatment at community centers is a falsehood," she added.

Bulgaru said that the new medication will be compared to the standard of care so that it may one day become a new standard of care. Drug trials go through several different stages, but once they get to phase three, they've already been approved for safety and efficacy.

The drug is produced by Roche and Genentech. To be approved for the study, one's cancer must be recurring either locally or to another organ and one must have been HER2 positive.

ECHO is participating in 45 different clinical trials for various cancers. Doctor of Pharmacy Susan Johnson looks for studies to offer.

As far as Gerber is concerned, a lot of progress has been made with breast cancer, but more is needed to combat the 40,000 deaths that occur each year. "There is a lot to be optimistic about, but people have to enroll in trials," she said.

"Clinical trials can give you hope. For women who have recurring breast cancer, it's devastating. Once you get past the emotional hump, something new can ignite hope," Gerber said.

You may be wondering why I was in southeastern Connecticut. It was for my annual sojourn to the Miss Connecticut Scholarship Pageant, for which I am an adult volunteer.

By the time you read this, we will have crowned the 2011 Miss Connecticut and Connecticut's Outstanding Teen. More about that another time.